inSIGHT Ultima ULTSYS-II
GUDID 00816734023112
inSIGHT Ultima Base System
DIVERSATEK HEALTHCARE, INC.
Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system| Primary Device ID | 00816734023112 |
| NIH Device Record Key | e1c89ff7-6256-41ce-a065-69f8e7a0bbfe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | inSIGHT Ultima |
| Version Model Number | ULTSYS-II |
| Catalog Number | ULTSYS-II |
| Company DUNS | 030650113 |
| Company Name | DIVERSATEK HEALTHCARE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816734023112 [Primary] |
FDA Product Code
| FFX | System, Gastrointestinal Motility (Electrical) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
On-Brand Devices [inSIGHT Ultima]
| 00816734023112 | inSIGHT Ultima Base System |
| 00816734023105 | inSIGHT Ultima Base Cart System |
| 00816734021958 | inSight Ultima® EMG Adaptor |
| 00816734021941 | InSight Ultima® Central Unit |
Trademark Results [inSIGHT Ultima]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSIGHT ULTIMA 86504174 4799320 Live/Registered |
Sandhill Scientific, Inc. 2015-01-15 |
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